BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES

    MDR report key: 19752323 · Received July 16, 2024

    Report

    Report Number
    1917413-2024-00637
    Event Type
    Malfunction
    Date Received
    July 16, 2024
    Date of Event
    June 12, 2024
    Report Date
    June 26, 2024
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    GIM
    UDI-DI
    30382903678564
    PMA / PMN Number
    BK230980
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE MEDICAL DEVICE TYPES: D2B: MEDICAL DEVICE TYPE: JKA. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: UNKNOWN. THERE WERE MULTIPLE 510K NUMBERS: G5. PMA / 510(K)#: K213670, K231373. H.6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. ADDITIONALLY, BD WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THIS COMPLAINT; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. THIS COMPLAINT IS UNABLE TO BE CONFIRMED. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THIS COMPLAINT WILL BE REOPENED TO ASSESS THE LEVEL OF INVESTIGATION NEEDED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES HAD TOO HIGH OF A VACUUM. THE PATIENTS WERE RECOLLECTED, AND NO FURTHER REPORT OF PATIENT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739031 BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE GIM BECTON, DICKINSON & CO. (BROKEN BOW) UNKNOWN 30382903678564

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown